Trial Outcomes & Findings for Effect of Oral Estradiol and Progesterone Therapy on Vaginal Cytokines in Postmenopausal Women (NCT NCT02224313)

Results Overview

Determine the differences in vaginal cytokines: interleukin (IL)-1β and IL-8 between premenopausal and postmenopausal women.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

20 participants

Primary outcome timeframe

At baseline visit

Results posted on

2020-03-19

Participant Flow

Participant milestones

Participant milestones
Measure	1.Premenopausal Women Premenopausal women with no treatment assigned	2.Postmenopausal Women With Hormones Oral hormone therapy will be given to women in this group. Daily dose of oral "estradiol" 1 mg will be given the first 14 days after enrollment. Then a daily dose of oral "estradiol" 1 mg and "progesterone" 100 mg for 14 days will be given during the following 14 days. oral estradiol 1.0 mg: one tablet of oral estradiol 1.0 mg once a day for 28 days oral progesterone 100 mg: one tablet of oral progesterone 100 mg once a day for 14 days
Overall Study STARTED	10	10
Overall Study COMPLETED	7	9
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Premenopausal Women n=10 Participants Premenopausal women at baseline	Postmenopausal Women n=10 Participants Postmenopausal women at baseline	Total n=20 Participants Total of all reporting groups
Age, Continuous	31.90 years STANDARD_DEVIATION 5.11 • n=10 Participants	56.44 years STANDARD_DEVIATION 3.57 • n=10 Participants	44.17 years STANDARD_DEVIATION 4.34 • n=20 Participants
Sex/Gender, Customized Women	10 Participants n=10 Participants	10 Participants n=10 Participants	20 Participants n=20 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	10 Participants n=10 Participants	10 Participants n=10 Participants	20 Participants n=20 Participants
Body mass index	30.06 kg/m^2 STANDARD_DEVIATION 5.82 • n=10 Participants	29.97 kg/m^2 STANDARD_DEVIATION 6.71 • n=10 Participants	30.02 kg/m^2 STANDARD_DEVIATION 6.08 • n=20 Participants
Vaginal power of hydrogen (pH)	4.08 pH STANDARD_DEVIATION 0.17 • n=10 Participants	6.33 pH STANDARD_DEVIATION 0.79 • n=10 Participants	5.21 pH STANDARD_DEVIATION 0.48 • n=20 Participants

PRIMARY outcome

Timeframe: At baseline visit

Population: One postmenopausal women was excluded due to non-compliance of assigned intervention.

Determine the differences in vaginal cytokines: interleukin (IL)-1β and IL-8 between premenopausal and postmenopausal women.

Outcome measures

Outcome measures
Measure	Premenopausal Women n=10 Participants Premenopausal women in the study	Postmenopausal Women n=9 Participants Postmenopausal women in the study
Vaginal Cytokines at Baseline IL-8	2.73 pg/ug protein Standard Deviation 3.67	3.19 pg/ug protein Standard Deviation 3.38
Vaginal Cytokines at Baseline IL-1β	0.12 pg/ug protein Standard Deviation 0.24	0.04 pg/ug protein Standard Deviation 0.04

SECONDARY outcome

Timeframe: At 14 days and 28 days follow-up

Population: Three premenopausal women were excluded due to missing data.

Determine the changes in vaginal cytokines in postmenopausal women following treatment with estradiol then estradiol and progesterone compared to the normal menstrual cycle changes in young premenopausal women.

Outcome measures

Outcome measures
Measure	Premenopausal Women n=7 Participants Premenopausal women in the study	Postmenopausal Women n=9 Participants Postmenopausal women in the study
Vaginal Cytokines During Follow-up IL-8 at 14 days	0.92 pg/ug protein Standard Deviation 1.40	1.34 pg/ug protein Standard Deviation 0.96
Vaginal Cytokines During Follow-up IL-1B at 14 days	0.02 pg/ug protein Standard Deviation 0.03	0.04 pg/ug protein Standard Deviation 0.07
Vaginal Cytokines During Follow-up IL-8 at 28 days	0.69 pg/ug protein Standard Deviation 0.33	1.69 pg/ug protein Standard Deviation 1.70
Vaginal Cytokines During Follow-up IL-1B at 28 days	0.04 pg/ug protein Standard Deviation 0.02	0.03 pg/ug protein Standard Deviation 0.04

Adverse Events

Premenopausal Women

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Postmenopausal Women

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr.David Archer

Eastern Virginia Medical School

Phone: 7574467444

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place